Managed Care Aspects of Managing Multiple Sclerosis

Published Online: November 26, 2013
Gary M. Owens, MD
Multiple sclerosis (MS) is a chronic disease of the central nervous system usually diagnosed in the second or third decade of life; MS is more common among women than men by a ratio of 3 to 1. With its relatively early age of onset and symptoms that impair patients’ quality of life, MS requires lifelong, dynamic treatment, and places a substantial economic burden on individuals, healthcare systems, and society. The costs associated with providing benefits for MS therapy are growing rapidly and the increasing complexity of the MS market is impacting disease management for payers. Employers are also increasingly aware of the costs associated with MS and are asking health plans to advise on the most appropriate and cost-effective ways to manage both pharmacologic and non-pharmacologic therapies for MS. Health plans, by necessity, must therefore balance appropriate access to treatments for MS with the need to manage rising treatment costs. To meet this goal, payers require population-based solutions, guidelines, and treatment algorithms for the management of MS that can be used in clinical and formulary management decision making in the context of an evolving therapeutic landscape. Further, comparative studies are necessary for payers to determine which agents may work best on a population basis. Due to the current lack of appropriate clinical guidance and insufficient head-to-head data on disease-modifying drugs, strategies for health plans and clinical management have been designed using the best available evidence. Undoubtedly, management of this class will continue to evolve with the launch of newer agents.

(Am J Manag Care. 2013;19(16):S307-S312)
Multiple sclerosis (MS) is a disease of the central nervous system that is diagnosed in 2 to 3 times as many women as men, most of whom are between the ages of 20 and 50 years.1,2 Because MS is characterized by inflammation and breakdown of the protective insulation surrounding nerve fibers (myelin), signals from within the brain and between the brain and body are disrupted, resulting in a variety of debilitating symptoms.3 Not only does MS degrade patient health-related quality of life (HRQoL),4-6 but the condition is also associated with a high economic burden for individuals, healthcare systems, and society.7-10 The overall burden of MS is substantial due to its early age of onset and its incurable, generally non-terminal nature, which necessitates lifelong treatment.

Payers have witnessed a rapid evolution of therapeutic treatment options for MS in recent years, as well as an increase in treatment costs over that time.5 Their clients, such as employers, have also experienced a significant rise in costs for patients with MS, and are asking payers to “justify” these growing expenses.8 Therefore, the treatment of MS is closely evaluated by payers, and as such, their needs for appropriately treating this illness include strategies that are population based, such as guidelines for the optimal management of patients that can be used in clinical and formulary management decision making, and methodologies to determine which agents will work effectively on individual patients from both the clinical and cost standpoints.

The Burden of Multiple Sclerosis

Managed care professionals and organizations must take into account that MS and its symptoms are associated with substantial personal, professional, and economic burdens. There are 4 subtypes of MS: (1) relapse-remitting (RRMS), (2) primary-progressive, (3) secondary-progressive (SPMS), and (4) progressive-relapsing (PRMS).11 The relapsing form of MS is the most commonly diagnosed form of MS and is marked by flare-ups, referred to as relapses or exacerbations, which are characterized by episodes of acute worsening of neurologic function.2,11 These flare-ups are followed by partial or complete recovery periods, referred to as remissions, that occur between attacks and are free of disease progression.11 Of the remaining subtypes of MS, SPMS and PRMS have unpredictable relapses and can result in a steady worsening and progression of the disease course, with approximately 50% and 90% of patients afflicted by RRMS progressing to SPMS after 10 years and 25 years, respectively.1,11 The very nature of MS makes the disease not only quite costly but also detrimental to patient HRQoL due to significant negative impact on physical functioning, vitality, and general health.4,7-10 Therefore, it is incumbent upon both managed care and healthcare authorities to develop effective strategies that increase patient HRQoL as well as reduce costs.

A decade ago, the average cost per patient in the United States who required hospitalization to manage the characteristic relapses of MS was $12,870 (in 2002 dollars).7 Subsequent US-based studies have reported similar if not greater total average annual costs for patients with MS, which were largely attributable to the high cost of prescription medications.8-10 Additionally, the results of the recently published MS Benchmarks Analysis revealed that the cost burden of MS varied according to the types of comorbidities and complications associated with MS such that costs (in 2009 dollars) were highest for those patients with ataxia ($31,483), followed by abnormality of gait ($31,175), muscle weakness ($29,104), spasms ($28,843), urinary incontinence ($28,561), and optic neuritis ($28,353).10 It should be noted that disease-modifying drugs (DMDs) accounted for 95% of the total annual pharmacy costs per patient, and 69% of the total costs for managing MS.10 Furthermore, 2 studies have reported a relationship between disease severity, impairments in HRQoL, and economic burden such that reductions in quality-adjusted life-years translated to estimated intangible costs that ranged from $7000 to $15,315 per patient, respectively.5,6

MS also places a high burden on occupational factors that affect patients, employers, and society as a whole. The results of several longitudinal studies have demonstrated that MS is tied to high unemployment rates, such that only 40% to 70% of persons with MS remain employed.6,12-15 Even for those patients who maintain employment, the impact of absenteeism and its consequences has been found to be quite high. The results of one study published in 2009 determined that, depending on the agent used for treatment, the annual number of days of sick leave used by employees with MS ranged from 2.98 to 8.13 days, with combined sick leave and short-term disability times ranging from 7.33 to 20.67 days, and costs associated with sick leave ranging from $523 to $1431 (inflation-adjusted to 2007 dollars).16 It is interesting to note that treatment may affect these outcomes. In a study of employees with untreated MS versus individuals who had at least 1 DMD claim, the risk-adjusted total annual medical and indirect costs were $6187 versus $4393 and $3053 versus $2252, respectively, with expenditures for treated employees found to be significantly lower (P <.0001 for both comparisons).17 Lastly, those responsible for providing care to patients with MS, such as parents, grandparents, spouses/partners, and other household members, may also experience a substantial negative impact on their own HRQoL due to spillover disutility and other collateral consequences.18

Medical and Pharmacy Cost Trends and the Employer Perspective

In 2012, 4 specialty classes accounted for over 75% of spend for specialty drugs: (1) inflammatory conditions, (2) MS, (3) cancer, and (4) human immunodeficiency virus.19 Moreover, in recent years, the healthcare and managed care communities have witnessed a progressive shift in spend away from medical benefits and toward pharmacy benefits, especially for newer oral agents that treat cancer or manage MS. Specialty pharmacy is the largest driver of cost increases for pharmacy in 2013,19 and based on pharmacy reports, employers are witnessing an undeniable growth of specialty pharmaceutical costs.

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